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NCT02316106 · OUTCOME

Time to Next Treatment (TNT) for Active Myeloma

A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma · Source last updated 2026-04-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
From randomization (Day -5) up to the date of first subsequent antimyeloma treatment (up to 7.89 years)

What was measured

Time to next treatment (TNT) for active myeloma were reported. Time to next treatment was defined as the time from the date of randomization to the date of the first subsequent multiple myeloma treatment. Kaplan-Meier estimate was used.

Analysis population: ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Groups in this outcome

Arm A (Long Intense)

Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).

Arm B (Intermediate)

Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).

Arm C (Short Intense)

Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A (Long Intense)10
Arm B (Intermediate)17
Arm C (Short Intense)23

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Long Intense)NANot reportedNANAHere, "NA" signifies that median, lower and upper limit of 90% CI were not estimable due to low number of participants with events.
Arm B (Intermediate)NANot reported59.9NAHere, "NA" signifies that median and upper limit of 90% CI were not estimable due to low number of participants with events.
Arm C (Short Intense)76.3Not reported40.480.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Here, "NA" signifies that median, lower and upper limit of 90% CI were not estimable due to low number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Here, "NA" signifies that median and upper limit of 90% CI were not estimable due to low number of participants with events.
        group Id
        OG001
        lower Limit
        59.9
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        40.4
        upper Limit
        80.3
        value
        76.3
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      23
    units
    Participants
description
Time to next treatment (TNT) for active myeloma were reported. Time to next treatment was defined as the time from the date of randomization to the date of the first subsequent multiple myeloma treatment. Kaplan-Meier estimate was used.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
    id
    OG000
    title
    Arm A (Long Intense)
  2. description
    Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
    id
    OG001
    title
    Arm B (Intermediate)
  3. description
    Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).
    id
    OG002
    title
    Arm C (Short Intense)
param Type
MEDIAN
population Description
ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From randomization (Day -5) up to the date of first subsequent antimyeloma treatment (up to 7.89 years)
title
Time to Next Treatment (TNT) for Active Myeloma
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice